UNIV - Research Program Coordinator I - Journeyman - Department of SCTR

Medical University of South Carolina•Charleston, SC

2d•$45,300 - $77,000•Onsite

About The Position

Serve as a Research Coordinator providing technical and professional services within the SCTR’s Research Nexus Research Coordination and Management (RCM) fee for service component. The position will assist Principal Investigators (PI) involved in the coordination of human subject activities as delegated by the PI. Responsibilities may include the recruitment of study participants, scheduling study visits, data collection, conducting research assessments and managing and maintaining up to date regulatory files.

Requirements

A bachelor's degree and two years of relevant program experience.

Responsibilities

Independently develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.
Screens participants for all studies independently, maintains subject level documentation for all studies independently, may train others on Good Clinical Practice Guidelines related to study documentation.
Conducts study visits and may perform complex research assessments, extracts complex data from electronic medical records and may train others on protocol specific testing/interviews.
Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject’s protection regulations in the informed consent process.
Acts as a regulatory authority or advisor, or trains and/or educates others and/or advises research teams on regulatory matters, may manage multi-site regulatory documents independently.
Creates regulatory submissions and annual reports to regulatory authorities and funding agencies (NIH, FDA, etc.) and completes required supplemental regulatory documents (IND/IDE, Certificate of Confidentiality, etc.) for all studies and trains other staff in these tasks.
Acts as a liaison for multi-site studies, managing regulatory submissions and reporting across all participating sites and with the IRB of record.
Assists with management and tracking of Investigational Products (IP) at the protocol and subject level employing required systems for handling, dispensing, and documenting IP for investigator-initiated protocols.
Collects, prepares, ships, and/or maintains inventory of research specimens and provides guidance on system improvements related to specimen handling.
Corrects audit/monitor findings independently.
Collects, prepares, or processes adverse event information independently.
Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Reviews study participant charges, identifies discrepancies and escalates to appropriate offices to ensure billing compliance.
Completes case report forms and enters data into EDC systems(s). Resolves data queries.
Creates complex data collection forms (CRFs and/or source documents) accordingly to protocol. Exports data to include simple data analysis, and/or reporting of data.
Makes recommendations to investigators and oversight organizations regarding site resources, recruitment, and budget feasibility for a clinical trial.
Develops study protocol specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Ensures study teams are compliant with institutional requirements/policies. Provides training to staff around these policies and ensures appropriate study specific training plans per the Delegation of Authority Logs.
Coordinates efforts and data for external monitoring boards and independently facilitates and submits the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest.
Employs safeguards for human subject protection and/or ensures vulnerable population regulations are adhered to and mitigated.
Proactively identifies potential problems and risks to the participant, study investigator, research team, and institution and implements conflict management plans per regulations and institutional policies.
Identifies research barriers and takes part in a committee, taskforce, or ad hoc group to address. Develops tools to disseminate to other research teams.
Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, labs, imaging, NEXUS, and MUSC Hospital services.
Other duties as required.